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Method Validation Specialist

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

**Job Opportunity:** We are seeking a highly skilled Method Validation Specialist to join our team.

Responsibilities:
  • Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and quality requirements.
  • Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines.
  • Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards.

**Expertise Needed:

  • Proven experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries.
  • Strong expertise in analytical and microbiological methods and their application in product development.
  • Excellent attention to detail and analytical skills with a focus on data integrity and accuracy.
  • Ability to work effectively in a team-oriented environment and collaborate across multiple departments.

**Required Qualifications:

  • Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required.
  • Advanced degree (Master's or Ph.D.) in a related field is preferred.
  • Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries.

**What You Will Gain:

  • Invaluable hands-on experience working alongside seasoned experts.
  • Opportunity to learn and grow in a supportive environment.
  • Gain exposure to the entire software development lifecycle.
  • Contribute to real-world projects and make a positive impact.
Benefits:

Remote work option available. May require occasional travel to other sites or meetings. Ability to work in a laboratory environment with exposure to chemicals and biohazardous materials.